Safety Study of AMG 228 to Treat Solid Tumors

Phase 1

Terminated

• Conditions: Oncology; Oncology Patients; Tumors; Transitional Cell Carinoma of Bladder; Advanced Malignancy; Advanced Solid Tumors; Cancer; Melanoma; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck
• Interventions: Drug: AMG 228

• Registration Number: NCT02437916
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-03
• Study Start: 2015-04-21
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
• Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria

• Active autoimmune disease, history of autoimmune disease
• Treatment with immune modulators including
• Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
• Major surgery within 28 days of study day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 228 monotherapy	AMG 228	Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.

Primary Outcome Measures

Name	Time	Method
AMG 228 maximum observed concentration (Cmax)	9 months
Subject incidence of dose limiting toxicities (DLT)	9 months
Subject incidence of treatment-emergent adverse events	9 months
Subject incidence of treatment-related adverse events	9 months
Subject incidence of clinically significant changes in vital signs and physical assessments	9 months
Subject incidence of clinically significant changes in ECGs	9 months
Subject incidence of clinically significant changes in clinical laboratory tests	9 months
AMG 228 minimum observed concentration (Cmin)	9 months
AMG 228 area under the concentration-time curve (AUC)	9 months
AMG 228 half-life (t1/2)	9 months

Secondary Outcome Measures

Name	Time	Method
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	9 months
Incidence of anti-AMG 228 antibody formation	9 months
Activation status of cytotoxic T lymphocytes (CTL)	9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)	9 months
Activation status and changes in numbers of T regulator cells (Treg)	9 months
Subject objective response per immune-related Response Criteria (irRC)	9 months

Trial Locations

Locations (1)

Research Site; 🇩🇪 Heidelberg, Germany